MCDG Gui­dance on Artic­le 16 MDR

Obli­ga­ti­ons of dis­tri­bu­tors and importers con­cer­ning repack­a­ging and labe­l­ing of medi­cal devices

Artic­le 16 MDR iden­ti­fies cases whe­re the manufacturer’s obli­ga­ti­ons also app­ly to importers, dis­tri­bu­tors and other persons

Importers and dis­tri­bu­tors may have manu­fac­tu­ring obli­ga­ti­ons in accordance with Artic­le 16 MDR in cer­tain cases. For details, see our pre­vious news (focus on importers, appli­es accor­din­gly to dis­tri­bu­tors). The fol­lo­wing are cases from Artic­le 16(2) MDR

  • invol­ving the chan­ge of the outer pack­a­ging of a pro­duct alre­a­dy on the mar­ket, inclu­ding the chan­ge of packa­ge size and rela­be­l­ing, as well as
  • the pro­vi­si­on of infor­ma­ti­on for use, inclu­ding trans­la­ti­on into the lan­guage of the mem­ber state.

Importers and dis­tri­bu­tors must ensu­re that the­se acti­vi­ties are car­ri­ed out under con­di­ti­ons that gua­ran­tee that the ori­gi­nal con­di­ti­on of the pro­ducts can­not be affec­ted as a result.

Artic­le 16(3) of the MDR the­r­e­fo­re requi­res that dis­tri­bu­tors and importers “have in place a qua­li­ty manage­ment sys­tem that includes pro­ce­du­res which ensu­re that the trans­la­ti­on of infor­ma­ti­on is accu­ra­te and up-to-date, and that the acti­vi­ties men­tio­ned [abo­ve] are per­for­med by a means and under con­di­ti­ons that pre­ser­ve the ori­gi­nal con­di­ti­on of the device and that the pack­a­ging of the repacka­ged device is not defec­ti­ve, of poor qua­li­ty or untidy.”

In accordance with Artic­le 16(4) MDR, a cor­re­spon­ding qua­li­ty manage­ment sys­tem of importers and dis­tri­bu­tors must be cer­ti­fied by a noti­fied body.

Gui­dance docu­ment MDCG 2021–23

In prac­ti­ce, this requi­re­ment poses par­ti­cu­lar chal­lenges for a lar­ge num­ber of importers and dis­tri­bu­tors, but also for noti­fied bodies. The­re was spe­cu­la­ti­on and dis­cus­sion about the set­ting and scope of the requi­red qua­li­ty manage­ment sys­tem on the one hand, the inspec­tion con­tents of the noti­fied bodies and the mini­mum details of the cer­ti­fi­ca­tes to be issued by them. With the MDCG 2021–23 gui­dance docu­ment (PDF) the Medi­cal Device Coor­di­na­ti­on Group (MDCG) has set its­elf the goal, among other things, of show­ing importers and dis­tri­bu­tors the mini­mum requi­re­ments for a QM sys­tem requi­red of them.

Mini­mum requi­re­ments for a QM sys­tem of dis­tri­bu­tors and importers

The mini­mum requi­re­ments for an appro­pria­te QM sys­tem are sta­ted in MDCG 2021–23:

  • docu­men­ta­ti­on of the manage­ment system,
  • Resour­ce manage­ment, inclu­ding pre­mi­ses and equip­ment neces­sa­ry to car­ry out acti­vi­ties refer­red to in Artic­le 16(2)(a) and (b) MDR, as well as sel­ec­tion and con­trol of sup­pli­ers and sub-contractors,
  • poli­ci­es for assign­ment of acti­vi­ties and respon­si­bi­li­ties to per­son­nel ensu­ring the avai­la­bi­li­ty of resour­ces and infor­ma­ti­on neces­sa­ry to sup­port the ope­ra­ti­on and moni­to­ring of the acti­vi­ties mentioned,
  • pro­ce­du­res ensu­ring that the dis­tri­bu­tor or importer is infor­med of any cor­rec­ti­ve action taken by the manu­fac­tu­rer in rela­ti­on to the device in ques­ti­on in order to respond to safe­ty issues or to bring it into con­for­mi­ty with the Regulation,
  • manage­ment of cor­rec­ti­ve actions inclu­ding pro­ce­du­res for hand­ling non-conforming devices and mar­ket recalls due to the acti­vi­ties car­ri­ed out under Artic­le 16(2)(a) and (b), inclu­ding, when neces­sa­ry, field safe­ty cor­rec­ti­ve actions and veri­fi­ca­ti­on of their effectiveness,
  • pro­ce­du­res to ensu­re tracea­bi­li­ty of the devices as well as labels, ins­truc­tions for use and outer pack­a­ging indi­ca­ting the chan­ges made to the product,
  • con­trol of documents,
  • con­trol of records,
  • super­vi­si­on of the imple­men­ta­ti­on and main­ten­an­ce of the qua­li­ty manage­ment system.

Over­all, the qua­li­ty manage­ment sys­tem should be capa­ble of sup­port­ing and demons­t­ra­ting the con­sis­tent achie­ve­ment of the requi­re­ments of Artic­le 16(3) MDR.

Impact on con­tract design

In addi­ti­on, by high­light­ing the neces­sa­ry con­trac­tu­al arran­ge­ments, the MDCG sheds light on ano­ther point that is essen­ti­al for eco­no­mic actors to coope­ra­te with each other. It empha­si­s­es that infor­ma­ti­on requi­re­ments should also be included in importers’ and dis­tri­bu­tors’ con­tracts with manu­fac­tu­r­ers of the pro­ducts to ensu­re that the dis­tri­bu­tor or importer is infor­med in a time­ly man­ner of any cor­rec­ti­ve action taken by the manu­fac­tu­rer with respect to the rele­vant pro­duct to address safe­ty issues or bring the pro­duct into com­pli­ance with the Regu­la­ti­on. In addi­ti­on, the con­tract bet­ween the noti­fied body and the dis­tri­bu­tor or importer should pro­vi­de for the pos­si­bi­li­ty of the noti­fied body being aut­ho­ri­sed to con­duct on-site audits at the pre­mi­ses of the dis­tri­bu­tors and importers them­sel­ves, but also at their subcontractors.

Recom­men­da­ti­on for action

Gui­dance docu­ments of the MDCG are, as the name sug­gests, recom­men­da­ti­ons or gui­de­lines; they are not legal­ly bin­ding. Nevert­hel­ess, as the recom­men­da­ti­on from a group of experts, they pro­vi­de valuable sup­port for eco­no­mic actors when it comes to imple­men­ting the MDR requi­re­ments.

The requi­re­ments for the QM sys­tem at importers and dis­tri­bu­tors are new; noti­fied bodies are scar­ce and busy and also con­fron­ted with the “new” regu­la­ti­ons. In order to pass an audit quick­ly and wit­hout devia­ti­ons, importers and dis­tri­bu­tors are the­r­e­fo­re well advi­sed to deal with the con­tents of Artic­le 16 MDR and to fol­low the recom­men­da­ti­ons of the MDCG with regard to the imple­men­ta­ti­on and scope of a qua­li­ty manage­ment sys­tem. The same appli­es to the inclu­si­on of the (from the MDCG’s point of view) par­ti­cu­lar­ly rele­vant infor­ma­ti­on obli­ga­ti­ons and on-site audit opti­on in con­tracts with manu­fac­tu­r­ers and noti­fied bodies.


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